Effect of CPP-ACP Paste on Dental Caries in Primary Teeth

Dental Caries Clinical Trial

Official title:

Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604109
• Other study ID #: TU-Dent-01
• Secondary ID: D43TW007768
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2012
• Last updated: June 10, 2013
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.

Description:

The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.

CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 42 Months

Eligibility

Inclusion Criteria:

• Healthy Thai boys and girl aged between 2 1/2 - 3 1/2

• Normal development of dentition

• Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)

Exclusion Criteria:

• Chronic use of medications or antibiotics.

• Lack of cooperation in oral examination

• Milk protein allergy and/or benzoate preservatives

• Presence at baseline oral soft tissue lesion and enamel hypoplasia.

• Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• 10 % w/v CPP-ACP paste
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
• the paste without CPP-ACP
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

Locations

Country	Name	City	State
Thailand	Faculty of Dentistry, Thammasat University	Klongluang	Patumthani

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Mean Number of Enamel Carious Lesion	tooth surface that was classified as ICDAS code 1-3	one calender year	No
Secondary	Quantitative Light-induced Fluorescence (QLF) Parameters	percent fluorescence loss, lesion area, lesion volume	one calender year	No